Medical Technology News | MedTech Dive
WEBPolitan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.
Abbott and Dexcom are launching the first over-the-counter …
WEBJun 26, 2024 — The new devices could allow the companies to reach about 25 million people in the U.S. with Type 2 diabetes who don’t take insulin, 15 million people who have been diagnosed with pre-diabetes and an estimated 85 million people who have undiagnosed pre-diabetes, William Blair analyst Margaret Kaczor Andrew said in an interview.
FDA flags 428 spinal cord stimulator patient deaths, urges more …
WEBSep 4, 2020 — The 107,728 MDRs received by FDA in the four-year period following July 27, 2016, include reports of 428 individual deaths of patients implanted with SCSs between 2005 and 2020. Almost one-third of cases where times to event were available happened in the 30 days after implantation. Many of the patients …
iRhythm analysis shows savings from patients wearing Zio XT …
WEBNov 7, 2022 — An analysis presented at the American Heart Association’s 2022 Scientific Sessions demonstrated the cost effectiveness of using iRhythm’s Zio XT patch to screen for atrial fibrillation. The results showed an incremental cost-effectiveness ratio of $17,000 per quality-adjusted life year gained, the academic standard for measuring how well ...
The top medtech trends in 2024
WEBJan 31, 2024 — Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year. Growing procedure volumes and remaining backlogs for certain surgeries could propel device companies to a successful 2024. JohnnyGreig via Getty Images.
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose ...
WEBJul 26, 2024 — Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect ...
Robot reveal: Intuitive submits 510(k) for next-generation system
WEBJan 24, 2024 — Q4 da Vinci placements: 415. Intuitive Surgical CEO Gary Guthart disclosed plans for a fifth-generation da Vinci robot on the company’s quarterly earnings call Tuesday, confirming speculation circulating among analysts. The robotic surgery leader submitted a 510 (k) application for da Vinci 5 to the Food and Drug Administration in August ...
MedTech Mergers & Acquisitions | MedTech Dive
WEB4 days ago — Merit Medical inks $210M takeover of Cook’s lead management business. Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales. By Nick Paul Taylor • …
Synchron brain-computer interface implanted in first 6 US patients
WEBSep 6, 2023 — Synchron, which is developing a brain-computer interface that aims to restore functionality in people with severe paralysis, said Tuesday that six patients have received the implant in the company’s U.S.-based feasibility study. The milestone marks the completion of enrollment in the COMMAND trial, conducted under the first investigational ...
Abbott device approval sets up battle with Medtronic, Nevro for ...
WEBFeb 6, 2023 — The procedure is covered by most major insurers. While the devices are expensive, some studies show they can decrease long-term health care costs for patients, Mayo Clinic neurologist Dr. Narayan Kissoon wrote in an email. Implanting a spinal cord stimulator can cost $32,000 for Medicare and as much as $58,000 for commercial insurers, according to the Journal of Neurosurgery.